TriLEAP Plating System by CrossRoads Extremity Systems

The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

Device Description

The TRILEAP Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, and variable angle locking screws available in various sizes.

AI/ML Overview

This document describes the FDA's clearance of the TRILEAP Plating System, a metallic bone fixation device. The focus of the provided text is on demonstrating the substantial equivalence of this new device to existing predicate devices through non-clinical performance data, rather than on a study proving the device meets acceptance criteria for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment methods for an AI/ML device is not applicable to this submission.

The provided text only discusses non-clinical performance data for the TRILEAP Plating System as follows:

1. A table of acceptance criteria and the reported device performance:

Test Method	Acceptance Criteria	Reported Device Performance
Plate Cross-Section Analysis (Bending Strength)	Not explicitly stated, implied to be comparable to predicate devices.	Not explicitly reported, implied to meet equivalence to predicates.
Screw Torsional Strength Analysis (ASTM F543 via FEA)	From FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)".	Not explicitly reported, implied to meet equivalence to predicates.
Screw Driving Torque (ASTM F543)	From FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)".	Not explicitly reported, implied to meet equivalence to predicates.
Screw Pull-Out (Chapman Equation)	Not explicitly stated, implied to be comparable to predicate devices.	Not explicitly reported, implied to meet equivalence to predicates.

Summary of what's not in the document:

Sample sized used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Explanation of the Study (as described in the document):

The study was a non-clinical performance evaluation conducted to demonstrate the substantial equivalence of the TRILEAP Plating System to predicate devices. The study involved:

Non-clinical Performance Data: The following analyses were conducted:
- Plate Cross-Section Analysis (Bending Strength)
- Screw Torsional Strength Analysis according to ASTM F543 via a Finite Element Analysis model
- Screw Driving Torque according to ASTM F543
- Screw Pull-Out via the Chapman Equation
Acceptance Criteria Source: Screw testing utilized acceptance criteria from the FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)". For other tests, acceptance was implicitly based on demonstrating similarity or equivalence to the predicate devices.
Conclusion: The results of the non-clinical performance data demonstrated that the subject devices are substantially equivalent to the predicate devices, and any differences in technological characteristics do not raise new questions of safety and effectiveness.

Clinical Performance Data: The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

Summary

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September 29, 2023

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CrossRoads Extremity Systems Keith Knapp Regulatory Affairs Specialist 6423 Shelby View Dr., Suite 101 Memphis, Tennessee 38134

Re: K230591

Trade/Device Name: TRILEAP Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 14, 2023 Received: August 23, 2023

Dear Keith Knapp:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tejen D. Soni -S

For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair

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and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230591

Device Name TRILEAP Plating System

Indications for Use (Describe)

The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sponsor	CrossRoads Extremity Systems, LLCKeith Knapp6423 Shelby View Dr, Suite 101Memphis, TN, 38134, USAPhone: +1-610-719-5942
Date Prepared	03/02/2023
Proprietary Name	TRILEAP Plating System
Device CommonName	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories. (Primary)Smooth or threaded metallic bone fixation fastener.
Classification	Class IIRegulation Number: 21 CFR 888.3030 (Primary) & 888.3040Product Code: HRS (Primary), HWC
Primary PredicateDevices	Synthes 2.4mm/2.7 mm Variable Angle LCP forefoot/ Midfoot System(K100776)
Additional PredicateDevices	MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision BunionSystem, DynaMET™ Lesser TMT Fusion System (K223342)
Device Description	The TRILEAP Plating System is intended for reduction, temporary fixation,fusion and stabilization of bones. The system consists of a family ofimplantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mmnon-contoured and anatomic procedure specific plates, cortical screws, andvariable angle locking screws available in various sizes.
Indications for use	The TRILEAP™ Plating System is indicated for fixation of bones and bonefragments of the foot and ankle in adults and adolescents (aged 12 -21years) where the growth plates have fused.
Non-clinicalPerformance Data	The following analyses were conducted for TRILEAP Plating System. Screwtesting utilized acceptance criteria from the FDA Guidance, "OrthopedicNon-Spinal Metallic Bone Screws and Washers – Performance Criteria forSafety and Performance Based Pathway (December 2020)".• Plate Cross-Section Analysis (Bending Strength)• Screw Torsional Strength Analysis according to ASTM F543 via aFinite Element Analysis model• Screw Driving Torque according to ASTM F543
	Screw Pull-Out via the Chapman Equation
ClinicalPerformance Data	Clinical testing was not necessary for the determination of substantialequivalence.
SubstantialEquivalence	The proposed subject devices have the same intended uses as the predicatedevices. The proposed subject devices share similar indications, are similarin design, material, and fundamental technology with the identifiedpredicate devices.
	The testing and analytical evaluation included in this submissiondemonstrate that: Any differences in technological characteristics of the predicatedevices do not raise any new questions of safety and effectiveness The proposed devices are at least as safe and effective as thepredicate devices
Conclusion	In conclusion, the results of non-clinical performance data demonstrate thatthe subject devices are substantially equivalent with the predicate devices.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.